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510(k) Data Aggregation

    K Number
    K212962
    Device Name
    TRELLIS™ SI Joint Fusion System
    Date Cleared
    2022-04-11

    (207 days)

    Product Code
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    OrthoFundamentals, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OrthoFundamentals TRELLIST™ SI Joint Fusion and Stabilization Implant System is intended for fixation of sacroiliac joint disruptions, and intended for sacroiliac joint fusion for conditions including: Sacroiliac joint disruptions Degenerative sacroiliitis To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
    Device Description
    The TRELLIS™ SI Joint Fusion System is a multiple component system consisting of sterile single use accessory instruments and sterile individually packaged screws of various lengths and diameters. The screws are designed to compress and stabilize the sacroiliac joint during the fusion process. They are self-tapping and are designed with a porous mid-shaft region to allow bone to grow onto and into its surface. The cannulated screws have axial fenestrations that allow bone through growth and packing with autograft bone or allograft material. The screws are designed to promote bony fusion onto and into the implant through the macro-surface topography which is generated through EBM additive manufacturing. The fenestration geometry harvests autograft during insertion which helps create an environment for bony in-growth and on-growth.
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